No

Growth Factor, Platelet-derived; Topical Skin Product

Debridement adjunct for the treatment of diabetic ulcers that occur on the lower limbs and feet

C

Hypersensitivity to becaplermin or any component of its formulation; known neoplasm(s) at the site(s) of application; active infection at ulcer site

Concurrent use of corticosteroids, cancer chemotherapy, or other immunosuppressive agents; ulcer wounds related to arterial or venous insufficiency. Thermal, electrical, or radiation burns at wound site. Malignancy (potential for tumor proliferation, although unproven; topical absorption is minimal). Should not be used in wounds that close by primary intention. For external use only.

<1%: Erythema with purulent discharge, ulcer infection, tunneling of ulcer, exuberant granulation tissue, local pain, skin ulceration

Refrigerate at 2°C to 8°C (36°F to 46°F); do not freeze

Recombinant B-isoform homodimer of human platelet-derived growth factor (rPDGF-BB) which enhances formation of new granulation tissue, induces fibroblast proliferation, and differentiation to promote wound healing

Onset: Complete healing of diabetic ulcers in 15% of patients within 8 weeks and 25% of patients at 10 weeks

Absorption: Systemic absorption is minimal

Distribution: Binds to PGDF-beta receptors in normal skin and granulation tissue

Adults: Topical:

The amount of becaplermin to be applied will vary depending on the size of the ulcer area. To calculate the length of gel applied to the ulcer, measure the greatest length of the ulcer by the greatest width of the ulcer in inches. Tube size will determine the formula used in the calculation. For a 15 or 7.5 g tube, multiply length x width x 0.6. For a 2 g tube, multiply length x width x 1.3.

Note: If the ulcer does not decrease in size by ~30% after 10 weeks of treatment or complete healing has not occurred in 20 weeks, continued treatment with becaplermin gel should be reassessed.

Ulcer volume (pressure ulcers); wound area; evidence of closure; drainage (diabetic ulcers); signs/symptoms of toxicity (erythema, local infections)

None reported

None reported

No information available to require special precautions

No effects or complications reported

Hands should be washed thoroughly before applying. The tip of the tube should not come into contact with the ulcer or any other surface; the tube should be recapped tightly after each use. A cotton swab, tongue depressor, or other application aid should be used to apply gel.

Step-by-step instructions for application:

Squeeze the calculated length of gel on to a clean, firm, nonabsorbable surface (wax paper)

With a clean cotton swab, tongue depressor, or similar application aid, spread the measured gel over the ulcer area to obtain an even layer

Cover with a saline-moistened gauze dressing. After ~12 hours, the ulcer should be gently rinsed with saline or water to remove residual gel and covered with a saline-moistened gauze dressing ( without gel).

Gel, topical: 0.01% (2 g, 7.5 g, 15 g)